(9 days)
Used for ultrasonic procedures: 1) All general subgingival scaling applications; 2) Periodontal debridement for all types of periodontal diseases; and 3) Endodontic procedures.
Used for ultrasonic procedures:
- . All general supra and subgingival scaling applications
- Periodontal debridement for all types of periodontal diseases .
- . Endodontic procedures
The Modified Device consists of the BOBCAT® Pro Ultrasonic Scaler with handpiece and DENTSPLY's 25K Ultrasonic Inserts.
The Scaler is a 25K ultrasonic scaler that operates over the frequency range of 23.5 - 25.7 kHz. The Scaler is available in various voltage inputs.
This 510(k) premarket notification (K033705) is for the DENTSPLY BOBCAT® PRO SCALER SYSTEM, an ultrasonic scaler. The document focuses on establishing substantial equivalence to a predicate device (K834283), rather than presenting a study with specific acceptance criteria and performance data in the context of typical AI/software medical device submissions.
Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information where available.
Acceptance Criteria and Device Performance
Based on the provided document, the "acceptance criteria" are implied to be the device meeting the safety and effectiveness standards such that it is substantially equivalent to the predicate device. The "reported device performance" is not quantified in the typical sense of a clinical trial or algorithm output, but rather asserted through design and material equivalence.
| Criteria | Reported Device Performance (Implied) |
|---|---|
| Safety and Effectiveness | Device is safe and effective for its intended uses. Materials are safe for dental use. |
| Intended Use Equivalence | Same intended uses as predicate device K834283. |
| Technological Characteristics Equivalence | Design modifications (electronic components, unit/handpiece material, ultrasonic inserts) do not change fundamental scientific technology or principles of operation. Materials have prior use in legally marketed devices. |
Study Details (Not Applicable as Per Type of Submission)
This submission is a premarket notification for substantial equivalence, not a clinical study or performance study in the way one would evaluate an AI or software device. Therefore, most of the requested information regarding sample size, data provenance, ground truth, experts, adjudication, and reader studies are not present or applicable.
- Sample size used for the test set and the data provenance: Not applicable. No test set mentioned for performance evaluation in the typical sense. The evaluation is based on design and material changes relative to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI or software product that assists human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device.
- The type of ground truth used: Not applicable in the context of an algorithm's performance. The "ground truth" for this submission would be regulatory compliance and equivalence to a predicate device based on manufacturing specifications and material safety.
- The sample size for the training set: Not applicable. No training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/21 description: The image is a close-up of a corner of a document or object. The corner is triangular in shape with a curved edge. The surface appears textured or grainy, with a mix of light and dark areas, suggesting either a rough material or the presence of dirt or wear. The overall impression is that of a fragment or detail from a larger, possibly aged or weathered item.
510(k) SUMMARY
DENTSPLY
NAME & ADDRESS:
DENTSPLY International
P. J. Lehn Telefax
P. Jeffery Lehn CONTACT:
November 24, 2003 DATE PREPARED:
TRADE OR PROPRIETARY NAME: BOBCAT® PRO SCALER SYSTEM
872.4850 Ultrasonic Scaler CLASSIFICATION NAME:
G-106 DENTSPLY® Cavitron ® Ultrasonic Dental Unit K834283 PREDICATE DEVICES:
DESCRIPTION OF DEVICE: The Modified Device consists of the BOBCAT® Pro Ultrasonic Scaler with handpiece and DENTSPLY's 25K Ultrasonic Inserts.
The Scaler is a 25K ultrasonic scaler that operates over the frequency range of 23.5 - 25.7 kHz. The Scaler is available in various voltage inputs.
INTENDED USE: Used for ultrasonic procedures: 1) All general subgingival scaling applications; 2) Periodontal debridement for all types of periodontal diseases; and 3) Endodontic procedures.
TFCHNOLOGICAL CHARACTERISTICS: Design modifications made to the K834283 Unit include changes in electronic components, unit material and handpiece material, and the addition of ultrasonic inserts. The unit uses DENTSPLY's 25K inserts. There are no changes in intended use, fundamental scientific technology, or principles of operation.
All of the materials in the device have been used in legally marketed DENTSPLY devices or found to be safe for dental use.
We believe that the Modified Device is substantially equivalent to K834283, and that prior use of the materials in legally marketed devices and the data provided support the safety and effectiveness of the Modified Device for the intended uses.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 4 2003
Mr. P. Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872
Re: K033705
Trade/Device Name: Bobcat Pro Scaler System, Model G-130 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: November 24. 2003 Received: November 25, 2003
Dear Mr. Lehn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice. labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 -Mr. Lehn
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Patricia Ciceritteffe
Chiu Lin. Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
(As Required by 21 CFR 807.87(e)
510(K) Number (if known):
Device Name: BOBCAT PRO SCALER SYSTEM
Used for ultrasonic procedures:
- . All general supra and subgingival scaling applications
- Periodontal debridement for all types of periodontal diseases .
- . Endodontic procedures
These are the same intended uses as previously cleared for K834283.
Susan Runoey
(Division Sign-Off) Division of Anesthesiola , General Hospital.
510(k) Number: K032705
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.